Ed is Keynote Speaker at ComplianceKey. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical En........

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Software validation is much more than testing.We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Why should you attend this webinar?

Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices.